COMMISSION IMPLEMENTING REGULATION (EU) 2023/1144
of 9 June 2023
granting a Union authorisation for the single biocidal product ‘Bacticid IPA-N’ in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council
(Text with EEA relevance)
Article 1
Article 2
ANNEX
Summary of product characteristics for a biocidal product
Bacticid IPA-N
Product type 2 – Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)
Product type 4 – Food and feed area (Disinfectants)
Authorisation number: EU-0027679-0000
R4BP asset number: EU-0027679-0000
1.
ADMINISTRATIVE INFORMATION
1.1.
Trade name(s) of the product
Trade name(s) |
Bacticid IPA-N |
1.2.
Authorisation holder
Name and address of the authorisation holder |
Name |
Chemi-Pharm AS |
Address |
Tänassilma tee 11, 76406 Tänassilma küla, Saku vald Estonia |
|
Authorisation number |
EU-0027679-0000 |
|
R4BP asset number |
EU-0027679-0000 |
|
Date of the authorisation |
2.7.2023 |
|
Expiry date of the authorisation |
31.7.2032 |
1.3.
Manufacturer(s) of the product
Name of manufacturer |
AS Chemi-Pharm |
Address of manufacturer |
Tänassilma tee 11, 76406 Tänassilma küla, Saku vald, Harju maakond Estonia |
Location of manufacturing sites |
AS Chemi-Pharm, Tänassilma tee 11, 76406 Tänassilma küla, Saku vald, Harju maakond Estonia |
1.4.
Manufacturer(s) of the active substance(s)
Active substance |
Propan-1-ol |
Name of manufacturer |
OQ Chemicals GmbH (formerly Oxea GmbH) |
Address of manufacturer |
Rheinpromenade 4a, 40789 Monheim am Rhein Germany |
Location of manufacturing sites |
OQ Chemicals Corperation (formerly Oxea Coperation), 2001 FM 3057 TX, 77414 Bay City United States |
Active substance |
Propan-1-ol |
Name of manufacturer |
BASF SE |
Address of manufacturer |
Carl-Bosch-Str. 38, 67056 Ludwigshafen Germany |
Location of manufacturing sites |
BASF SE, Carl-Bosch-Str. 38, 67056 Ludwigshafen Germany |
Active substance |
Propan-1-ol |
Name of manufacturer |
SASOL Chemie GmbH & Co. KG |
Address of manufacturer |
Secunda Chemical Operations, Sasol Place, 50 Katherine Street, 2090 Sandton South Africa |
Location of manufacturing sites |
Secunda Chemical Operations, PDP Kruger Street, 2302 Secunda South Africa |
Active substance |
Propan-2-ol |
Name of manufacturer |
INEOS Solvent Germany GmbH |
Address of manufacturer |
Römerstrasse 733, 47443 Moers Germany |
Location of manufacturing sites |
INEOS Solvent Germany GmbH, Römerstrasse 733, 47443 Moers Germany INEOS Solvent Germany GmbH, Shamrockstrasse 88, 44623 Herne Germany |
2.
PRODUCT COMPOSITION AND FORMULATION
2.1.
Qualitative and quantitative information on the composition of the product
Common name |
IUPAC name |
Function |
CAS number |
EC number |
Content (%) |
Propan-1-ol |
|
Active Substance |
71-23-8 |
200-746-9 |
35,0 |
Propan-2-ol |
|
Active Substance |
67-63-0 |
200-661-7 |
35,0 |
2.2.
Type of formulation
3.
HAZARD AND PRECAUTIONARY STATEMENTS
Hazard statements |
Flammable liquid and vapour. Causes serious eye damage. May cause drowsiness or dizziness. Repeated exposure may cause skin dryness or cracking. |
Precautionary statements |
Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. – No smoking. Keep container tightly closed. Avoid breathing vapours. Use only outdoors or in a well-ventilated area. Wear eye protection.. IF INHALED:Remove person to fresh air and keep comfortable for breathing. IF IN EYES:Rinse cautiously with water for several minutes.Remove contact lenses, if present and easy to do. Continue rinsing. Immediately call a POISON CENTER/doctor. Store in a well-ventilated place.Keep cool. Store locked up. Dispose of container to an authorised waste collection point. |
4.
AUTHORISED USE(S)
4.1.
Use description
Product type |
PT02 – Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants) |
Where relevant, an exact description of the authorised use |
Not relevant |
Target organism(s) (including development stage) |
Scientific name: no data Common name: Bacteria Development stage: no data Scientific name: no data Common name: Yeasts Development stage: no data Scientific name: no data Common name: viruses (limited spectrum virucidal activity) Development stage: no data |
Field(s) of use |
Indoor Health care facilities and pharmaceutical and cosmetic industry, for example patient-near surrounding, working areas/desks, general equipment (excluding food contact surfaces): disinfection of small hard/non-porous surfaces. For professional use only. |
Application method(s) |
Method: Manual application Detailed description: Ready-to-use surface disinfectant at room temperature (20 ± 2 °C). The entire surface to be disinfected is wetted by pouring or spraying from a short distance and subsequently thoroughly wiped with a cloth. The amount of product should be sufficient (max. 50 ml/m2 to keep the surface wet during the contact time. |
Application rate(s) and frequency |
Application Rate: Minimum exposure time: — for the control of bacteria, yeasts and enveloped viruses: 60 sec — for the control of viruses (limited spectrum virucidal activity): 5 min Dilution (%): Ready-to-use product Number and timing of application: A reasonable frequency of disinfection in a patient’s room is 1-2 per day. Maximum number of applications is 6 per day. No safety intervals need to be considered between the application phases. |
Category(ies) of users |
Industrial Professional |
Pack sizes and packaging material |
100, 500, 750 and 1 000 ml transparent/white high-density polyethylene (HDPE) bottle with polypropylene (PP) flip top caps (accessory: PP screw closure with spray head); 5 000 ml transparent/white HDPE canister with HDPE screwed cap. |
4.1.1.
Use-specific instructions for use
4.1.2.
Use-specific risk mitigation measures
4.1.3.
Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
4.1.4.
Where specific to the use, the instructions for safe disposal of the product and its packaging
4.1.5.
Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
4.2.
Use description
Product type |
PT04 – Food and feed area (Disinfectants) |
Where relevant, an exact description of the authorised use |
Not relevant |
Target organism(s) (including development stage) |
Scientific name: no data Common name: Bacteria Development stage: no data Scientific name: no data Common name: Yeasts Development stage: no data |
Field(s) of use |
Indoor Health care facilities and in food industry, for example food preparation and handling in kitchens/restaurants: disinfection of small hard/non-porous surfaces. For professional use only. |
Application method(s) |
Method: Manual application Detailed description: Ready-to-use surface disinfectant at room temperature (20 ± 2 °C). The entire surface to be disinfected is wetted by pouring or spraying from a short distance and subsequently thoroughly wiped with a cloth. The amount of product should be sufficient (max. 50 ml/m2) to keep the surface wet during the contact time. |
Application rate(s) and frequency |
Application Rate: Minimum exposure time: for the control of bacteria and yeasts at 20 °C: 60 sec Dilution (%): Ready-to-use product Number and timing of application: The products can be used as often as necessary. A reasonable frequency in kitchens is 1-2 per day. No safety intervals need to be considered between the application phases. |
Category(ies) of users |
Industrial Professional |
Pack sizes and packaging material |
100, 500, 750 and 1 000 ml transparent/white high-density polyethylene (HDPE) bottle with polypropylene (PP) flip top caps (accessory: PP screw closure with spray head); 5 000 ml transparent/white HDPE canister with HDPE screwed cap. |